Kornimate/medical-research-clean huggingface dataset:
impact of blocking the glossopharyngeal nerve on gastroesophageal reflux disease

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore clinical effect of glossopharyngeal nerve block on pharyngeal dysphagia induced by gastroesophageal reflux disease. the main question it aims to answer is: • can glossopharyngeal nerve block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given glossopharyngeal nerve block once a day additionally. the study lasts 20 days for each participant. researchers will compare the rosenbek penetration-aspiration scale, gastroesophageal reflux disease questionnaire, pressure pain threshold, to see if the glossopharyngeal nerve block can help improve the symptom.

gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus. the goal of this clinical trial is to explore clinical effect of glossopharyngeal nerve block on pharyngeal dysphagia induced by gastroesophageal reflux disease. the main question it aims to answer is: • can glossopharyngeal nerve block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given glossopharyngeal nerve block once a day additionally. the study lasts 20 days for each participant. researchers will compare the rosenbek penetration-aspiration scale, gastroesophageal reflux disease questionnaire, pressure pain threshold, to see if the glossopharyngeal nerve block can help improve the symptom.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for gastroesophageal reflux disease. * age between 18 and 65 years. * confirmed tongue-pharyngeal nerve injury by electromyography. * esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia. * normal higher brain function, able to cooperate with treatment. exclusion criteria: * brain vascular disease diagnosed. * clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders. * concurrent presence of other neurological disorders such as alzheimer's disease, traumatic brain injury, parkinson's disease. * esophageal obstruction and severe liver or kidney dysfunction * subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc.
valproic acid for idiopathic nephrotic syndrome

Conditions: Idiopathic Nephrotic Syndrome; Focal Segmental Glomerulosclerosis; Minimal Change Disease

Summary: the trial investigates the use of vpa (valproic acid) for the treatment of adult patients with biopsy proven idiopathic focal segmentel glomerulosclerosis (fsgs) or minimal change disease (mcd). vpa used as an add-on to steroids might induce clinical remission in a first category of patients and potentially reduce the dose of maintenance immunosuppression required to maintain remission thereafter. in a second category of patients vpa might allow the reduction or even cessation of immunosuppression while clinical remission is maintained.

idiopathic mcd to treat diseases with a considerable associated morbidity and mortality. current treatment options are limited, have limited efficacy and a considerable side effect profile. recent findings in a murine model suggest that vpa treatment in an early phase of renal disease could halt or even prevent the development of proteinuria and the progression of kidney damage. vpa is a commonly used and easy available oral antiepileptic agent with a favorable side effect profile compared to the current standard of care agents for podocytopathies. this trial investigates wether 1. vpa on top of or in substitution of standard of care agents is effective in remission induction in patients with fsgs or mcd with proteinuria resistant to first line therapy with corticosteroids. 2. vpa is effective in remission maintenance allowing reduction and cessation of chronic immunosuppression without relapse in patients with frequently relapsing fsgs or mcd.

Eligibility criteria:
inclusion criteria: * able to give informed consent * biopsy proven idiopathic fsgs or mcd * organ function: * bilirubin/ast/alt\< 2 uln * plt\>100.000 10\*6/l * inr 1.5 except if on anti-vitamin k treatment * lipase \<1.5 uln * creatinine clearance \>30ml/min - exclusion criteria: * contraindication for vpa * secondary etiologies for fsgs or mcd * multiple organ transplantation * currently participating in another clinical trial * pregnant or lactating women * women unwilling to take efficient contraceptive measures for the duration of the study

Keywords: idiopathic podocytopathies neprology
bioforte technology for in silico identification of candidates for a new microbiome-based therapeutics and diagnostics

Conditions: Non Small Cell Lung Cancer; Microbiome; Metagenome; Immunotherapy; Melanoma

Summary: the goal of the project is to develop and validate the bioforte technology. its main functionality should be to in silico determine candidates for novel microbiome-based therapeutics and diagnostics. key challenge to be solved using the technology is to detect the differences in gut microbiome between oncology patients who respond to immunotherapies and the ones who do not respond to this treatment. this technology employs machine learning methods to replace the laboratory procedure for finding valuable genomic features. such features can be crucial to identify differences between the two populations (e.g. responders vs non-responders) to target specific strains. the samples and data collected in this clinical study will be used for clinical validation of bioforte technology. for all patients treated with immunotherapy, stool collection will be performed per patient (one stool collection before setting up immunotherapy using anti-pd1 / anti-pdl1 and / or anti ctla4 antibodies). samples will be sequenced by long-read sequencing technology. in parallel, we will also collect samples of peripheral blood samples (pbmc) and biopsy (ffpe).


Eligibility criteria:
inclusion criteria: * men or women ≥18 years of age. * patients with one of the following types of cancer: non-small cell lung cancer, melanoma. * patients with informed consent to participate in the study. * patients receiving routine treatment (immunotherapy using anti-pd1 / anti-pdl1 and / or anti ctla4 antibodies), financed by the polish national health fund (nfz). * the applied immunotherapy should be the first or second line of treatment. exclusion criteria: * patients who are unable to understand, read and / or sign informed consent. * patients who can not collect stools. * patients with fecal transplant. * the applied immunotherapy is not the first or second line of treatment.

Keywords: microbiome cancer metagenome non small cell lung cancer immunotherapy neoplasms nivolumab ipilimumab atezolizumab stool ffpe pbmc intestinal microbiota immuno-oncology melanoma
patient-derived organoids of lung cancer to test drug response

Conditions: Lung Cancer; Organoid

Summary: this is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 3 years. the purpose of this study is to evaluate the consistency and accuracy of a patient-derived organoid (pdo) model of lung cancer to predict the clinical efficacy of anti-cancer drugs, in order to predict the best chemotherapy regimen for each given patient.

the aim of the project is to use a combination of patient-derived organoid models: * to amplify tumour tissue to obtain enough material for genomic and histological analysis * to characterize the lung cancer sub-type * to predict treatment (non)response. the following points will be addressed: 1. first, the investigators plan to establish and characterize formation of organoids from biopsies of patients with lung cancer: in spheroids, in the 3d cellular model oncocilairtm (oncotheis), and on the chick chorioallantoic membrane (cam). patient-derived organoids from tumoural tissue (pdo) will be characterized and compared to the original tumour. 2. second, the investigators will test the chemoresponse (chemosensitivity and chemoresistance) of organoids to anti-cancer treatment.

Eligibility criteria:
inclusion criteria: * histologically proven lung cancer * age ≥ 18 * written informed and signed consent * accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour exclusion criteria: * less than 18 years of age * not able to give informed consent (language, intellectual capacities, etc.) * not accessible to biopsy and/or surgery sample * not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
effect of massage therapy on severity of restless legs syndrome and quality of life in hemodialysis patients

Conditions: Hemodialysis

Summary: the restless leg syndrome (rls) is among the most common problems for the individuals undergoing hemodialysis (hd) therapy. this randomized controlled trial was conducted to determine the effect of the massage, applied with 5% lavender oil for the individuals receiving hd therapy, in the first half of hd session three times a week for four weeks on both legs for 10 minutes in each leg, on severity of rls and quality of life. the study was completed with 58 patients including 31 people in the intervention group and 27 people in the placebo control group, in 7 hemodialysis centers located in a city center. the ethics committee approval, informed consent of the individuals and the institutional permission were obtained. the data were collected using the patient information form, rls severity rating scale, kidney disease quality of life questionnaire (kdqoltm-36) and patient follow-up charts. in accordance with the massage application protocol, those in the intervention group were massaged with lavender oil and those in the placebo group were massaged with baby oil. chi-square test, t test, repeated measures one-way analysis of variance, and pearson correlation analysis tests were used to assess the data. in the comparisons, the value of p\<0.05 was accepted as significant.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years * were not pregnant or did not plan pregnancy * were diagnosed with rls by a physician * had at least mild rls based on the rls severity rating scale * had received hd treatment in the hd units for at least 3 months and three sessions per week * had continued the dialysis treatment at the same institution * had not changed the treatment schedule before the massage therapy and throughout the study * could understand and communicate in turkish exclusion criteria: * patients with an allergy to lavender oil * had an open wound that would hinder the massage therapy * had lower leg problems such as neuropathy * had a neurological disease such as epilepsy, alzheimer's disease, parkinson's disease, or multiple sclerosis * had a history of other cit methods applied

Keywords: hemodialysis, restless leg, lavender oil, massage, quality of life
effect of a high-fat meal on the pharmacokinetics of shr0302 and mass balance study in healthy subjects

Conditions: Rheumatoid Arthritis

Summary: the purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg shr0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of shr0302 and mass balance study in 14 healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male * bmi:19-24 kg/m2, weight \> 50 kg. * age:18-45 exclusion criteria: * history of clinically significant laboratory results or disease. * history of alcohol or drug abuse.
minima stent system post- approval study (pas)

Conditions: Pulmonary Artery Stenosis; Aortic Coarctation

Summary: this post-approval study is a single arm, prospective, multi-center, open-label study of patients treated with the renata minima stent system in the united states. the objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.

a minimum of 100 subjects will be enrolled. follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. data collected at each follow-up will be used in analysis. this study will monitor key data points related to the device and procedure.

Eligibility criteria:
inclusion criteria: * the subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent * indicated for treatment with the minima stent system per the ifu. exclusion criteria: * active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation * history of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation * aortic or pulmonary artery aneurysm in the location targeted for treatment * body weight \< 1.5 kg * anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent * target vessels larger or smaller than the minima system balloon size ranges * known genetic syndrome known to be associated with vasculopathies such as but not limited to williams syndrome, loeys-dietz syndrome, etc * clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure. * currently participating in an investigational drug study or another device study * major or progressive non-cardiac disease resulting in a life expectancy of less than six months * known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications * known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated

Keywords: vascular stenosis minima minima stent minima stent system renata medical renata infant stent
demonstration of the dynamic hypothesis of latent tuberculosis infection

Conditions: Latent Tuberculosis Infection

Summary: it is traditionally considered that the development of latent tuberculosis infection (ltbi) is due to the m. tuberculosis ability to develop a dormancy state within well-structured lesions (granulomas), which can remain in the lung of the host even for life. a new original hypothesis has been developed in the experimental tuberculosis unit based on scientific evidence that take into account the idea that a lesion cannot be held forever, because the host tends to remove any lesion in order to rebuild the original parenchyma, in a healing process. even if m. tuberculosis can remain in a dormant/non-replicating state for a long period, this is an important but not sufficient factor to explain the ltbi. the dynamic hypothesis tries to explain the existence of ltbi in spite of the healing process that could remove it by a constant reinfection of the host's tissue. while the "static" view defends the induction of active tb after the reactivation of the bacilli from and old lesion; while the "dynamic" view wants to demonstrate that there is a constant induction of new granulomas. in case one of these new lesions takes place in the upper lobe privileged zone, the possibility to induce a cavity would appear, developing an active tuberculosis (tb).


Eligibility criteria:
inclusion criteria: * being at least 18 years old * to be m.tuberculosis infected (diagnosed by a positive tst with or without a positive result in the quantiferon-tb-gold in tube assay) exclusion criteria: * active tb * individuals not willing to participate in the study and or not willing to sign the informed consent form * individuals not able to decide their participation in the study
intragastric balloon for treatment of non alcoholic steatohepatitis (nash)

Conditions: Non Alcoholic Steatohepatitis

Summary: the study will determine the feasibility of using bioenteric intragastric balloon (bib) in the treatment of patients with non alcoholic steatohepatitis (nash).

the bio-enteric intra-gastric balloon (bib) has been shown to be an effective treatment for weight reduction in obese patients. this study will determine the feasibility of using bib in the treatment of patients with non alcoholic steatohepatitis (nash). it will evaluate the efficacy of the bib in improving histology of nash in obese patients.

Eligibility criteria:
inclusion criteria: * patients between 21-65 years of age, * had histological evidence of nash, * had a bmi of greater than 27kg/m2, and * had failed at least 6 month trial of medical therapy for weight reduction. exclusion criteria: * patients with any organic disease of the upper gi tract, * were receiving anti-inflammatory drugs, * anticoagulants or steroids, or * had a history of alcoholism or drug addiction. a hiatus hernia of \> 5 cm, an active gastric or duodenal ulcer, and prior or intestinal surgery were considered contraindications to the placement of bib.

Keywords: non alcoholic steatohepatitis intra-gastric balloon
biosignals by wearable devices in hypothyroidism

Conditions: Hypothyroidism

Summary: this is a prospective observational cohort study. monitoring continuous biosignals using wearable devices in thyroid cancer patients who are planned to withdraw their levothyroxine for radioactive iodine therapy. through this, bio signals can be collected in the subjects in hypothyroid status. physical activity, heart rate, and sleep data will be collected during the study period.

a prospective observational cohort study including two groups. hypothyroid group: patients with differentiated thyroid carcinoma underwent total thyroidectomy patients who are planned to withdraw their levothyroxine for radioactive iodine therapy biosignals will be monitored continuously using fitbit devices control group: patients with differentiated thyroid carcinoma underwent total thyroidectomy patients who are planned to get rhtsh (not to withdraw their levothyroxine) for radioactive iodine therapy biosignals will be monitored continuously using fitbit devices thyroid hormone levels and continuously collected bio signals including activity, heart rate, and sleep data will be obtained during study period. association between thyroid status and bio signals will be investigated.

Eligibility criteria:
inclusion criteria: * patients with differentiated thyroid carcinoma underwent total thyroidectomy * patients who are planned to get radioactive iodine therapy * patients who are able to use wearable device and smartphones exclusion criteria: * patients who are not able to use wearable device and smartphones * patients who are maintaining drugs affecting heart rate * patients who have any other disease which can affect biosignals
shared decision making for schizophrenia

Conditions: Schizophrenia

Summary: the impact of a decision aid for inpatients with schizophrenia on perceived involvement and compliance is studied in comparison with routine care.

to follow

Eligibility criteria:
inclusion criteria: * schizophrenia (icd10) * age 18 - 65 years * inpatients exclusion criteria: * mental retardation * no informed consent

Keywords: schizophrenia shared decision making compliance maintenance therapy
functional neuroimaging in depression

Conditions: Major Depression

Summary: oral administration of escitalopram during 8 weeks; pet scan with 18f-fdg at inclusion and after 8 weeks


Eligibility criteria:
inclusion criteria: * major depression, depressive episode, following dsm-iv criteria * madrs-score \> 25 * age: 18-65 yrs * medication-free or anti-depressant wash-out 7 days (for fluoxetine: 6 weeks) * lorazepam 1mg or zolpidem 10mg are allowed exclusion criteria: * suicidality * bipolar disorder, following dsm-iv criteria * psychotic symptoms * substance abuse * personality disorder, following dsm-iv criteria * cognitive dysfunction due to trauma capitis or dementia * diabetes mellitus * women without contraceptive protection, with pregnancy or breast feeding * pharmacological treatment or ingestion of substance that can influence cerebral perfusion less than a month before inclusion * iq below 80 * conditions not compatible with spc
liver elastography in patients undergoing treatment for hepatitis c

Conditions: Hepatitis C Virus Infection

Summary: according to the guidelines for treating hepatitis c livers stiffness (ls) measurement is equivalent to liver biopsy to prove grade-2 fibrosis or more by metavir-score. also flares of inflammation in other viral hepatitis (b) have been reported to increase the elastography measurements. there are very few reports so far on longitudinal data in a treatment cohort. in this study investigators will follow patients who undergo active treatment for hepatitis c virus (hcv). investigators will collect longitudinal data of liver elastography and compare this to the current status of liver inflammation by blood samples. this may be important in order to know if transcutaneous us with elastography can be used as a tool to monitor active inflammation in liver disease and to quantify how much the inflammatory component contribute to ls and finally if it is possible to reverse not only inflammation but also liver fibrosis by treating viral hepatitis. our aim is to assess shear wave elastography (swe) and investigate if the method can be used, not only to define the indication for treatment through ls measurements, but also if ls due to inflammation and fibrosis may be reversible in treated patients. to investigate what role frequency of measurement obtains in follow up of patients with hcv play.


Eligibility criteria:
inclusion criteria: * diagnosed with hcv * hcv rna positive * approved for hcv treatment exclusion criteria: * excessive alcohol use * pregnancy * information of other cause of chronic liver disease (autoimmune hepatitis (aih), primary sclerosing cholangitis (psc), primary biliary cholangitis (pbc), alpha-1-antitrypsin deficiency).

Keywords: ultrasound shear wave elastography swe hepatitis c hcv
study of sars-cov2 virus (covid-19) seroprevalence in the population of creil air force base (ba110)

Conditions: Sars-CoV2

Summary: in mid-february 2020, within the oise (france) cluster, a case of covid-19 disease caused by a sars-cov2 infection was described among the personnel of the creail air force base (ba110). this resulted in the beginning of an epidemic controlled by epidemiological measures. one month later, containment measures were taken at the national level, measures that also applied to ba110 personnel. these personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when france is lifting the containment measures. it becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible. the main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of covid-19.


Eligibility criteria:
inclusion criteria: * active military or civilian defence personnel working on the creil air force base (ba110) during the period of interest (from february 1st 2020 to the end of the study) exclusion criteria: * contraindication to blood sampling * pregnant, parturient, breastfeeding woman